One-Year Outcomes from ACURATE neo2 PMCF Registry Study
Study on ACURATE neo2, a 2nd-generation aortic valve system, focusing on 1-year outcomes in routine clinical practice. Key aspects include safety endpoints, core laboratory evaluations, and patient follow-up data. The study highlights improvements over the prior-generation ACURATE neo, with a specific emphasis on reducing paravalvular leak (PVL) and enhancing patient outcomes.
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One-year outcomes from the ACURATE neo2 PMCF Post-market Registry Won-Keun Kim, MD Kerckhoff-Klinik GmbH, Bad Nauheim, Germany On behalf of the ACURATE neo2 Post-Market Clinical Follow-up Study Investigators CAUTION: In Europe, ACURATE neo and neo2 Aortic Valve Systems are CE-marked. In the USA, ACURATE neo2 is an investigational device and restricted under federal law to investigational use only. Not available for sale. SH-1743303 AA
Potential conflicts of interest Speaker's name : Won-Keun Kim I have the following potential conflicts of interest to declare: Receipt of grants / research support: Boston Scientific Receipt of honoraria or consultation fees: Abbott, Boston Scientific, Edwards Lifesciences, Meril, Shockwave Medical PCRLondonValves.com SH-1743303 AA
Why this study? ACURATE neo2is a 2nd-generation supra-annular valve that features improvements to further reduce PVL compared to the prior-generation ACURATE neo. CE marked 2020 Self-expanding nitinol frame Top-down deployment The PMCF post-market registry studied neo2 in routine clinical practice. Porcine pericardial leaflets in a supra-annular position Enhanced sealing skirt Outcomes at 30 days have been previously presented. Here, we report 1-year outcomes. PCRLondonValves.com SH-1743303 AA
What did we study? Prospective multicentre single-arm post-market surveillance study in a routine clinical practice setting Independent CEC adjudication of safety events Primary safety endpoint: 30-day all-cause mortality Additional endpoints evaluated through 1 year Death, stroke, bleeding, major vascular complications, hospitalization for valve-related symptoms Independent core laboratories Echocardiography: MedStar Health Research Institute Hemodynamics and PVL at discharge, 30 days, and 1 year 4D-CT: The University of British Columbia, Department of Radiology Hypo-attenuated leaflet thickening (HALT) at 30 days [primary imaging endpoint] and 1 year PCRLondonValves.com SH-1743303 AA
How was the study executed? Intention-To-Treat N=250 Successfully Implanted N=246 Mean Age 80.8 6.2 yrs Device not in correct position n=4* 36.4% Male 63.6% Female 30-day Imaging Data Analyzed 30-day Clinical Follow-up Visit Completed or Death 94% (236/250) TTE: 91% (224/246) CT: 83% (204/246) Mean STS Score 2.9% 2.0% Premature discontinuation Withdrawal from study, n=20 Missed 1y follow-up, n=7 Operative Risk (per Heart Team) Low 1-year Imaging Data Analyzed High 37.2% 1-year 31.2% Clinical Follow-up Visit Completed or Death 89% (223/250) TTE: 76% (186/246) CT: 62% (153/246) Intermediate 31.6% *In 4 patients, ACURATE neo2 embolized and patients were implanted with a non-study valve; these patients were followed for safety only through 30 days Patient survival confirmed, but no additional follow-up data collected. SH-1743303 AA
What are the essential results? Key Safety Events All-cause mortality Cardiovascular mortality All stroke Major bleeding Hospitalization for valve-related symptoms or worsening CHF Prosthetic aortic valve thrombosis Prosthetic aortic valve endocarditis Valve-related repeat procedure (BAV) Discharge 0.4% (1) 30 Days 0.8% (2)* 1 Safety Endpt 1 Year 5.1% (12) 0.4% (1) 0.8% (2) 3.4% (8) 0.4% (1) 0.8% (2) 3.0% (7) 2.4% (6) 2.4% (6) 2.8% (7) 0.0% (0) 0.0% (0) 1.7% (4) 0.9% (2) 1.7% (4) 0.4% (1)^ 0.4% (1) 0.0% (0) 0.4% (1) 0.4% (1)* 0.8% (2) 0.4% (1) Newly implanted permanent pacemaker 5.2% (13) 6.1% (15) 7.8% (19) *Deaths: 1 patient experienced life-threatening bleeding (admitted to secondary hospital, source of bleeding not recorded) and hemodynamic instability leading to circulatory arrest and death; 1 patient died post index procedure following valve embolization and unsuccessful TAV-in-TAV with non-study valve leading to coronary obstruction and procedural myocardial infarction. *Surgical removal of embolized ACURATE neo2 valve ^Thrombus noted pre-discharge in non-study valve implanted subsequent to ACURATE neo2 embolization Diagnosis of HALT at 30 days and 1 year, with oral anticoagulant therapy initiated shortly before 1-year visit PCRLondonValves.com SH-1743303 AA
What are the essential results? Echocardiography Core Laboratory Aortic Valve Haemodynamics, ITT Population Paravalvular Leak, Paired Analysis (n=116) 100 2.0 1.7 0.4 (n=134) 1.6 0.4 (n=139) 1.6 0.4 (n=127) 0.9 1.9 15.3 16.2 22.6 80 1.6 Mean AV Gradient (mmHg). Severe Mean AV Area (cm2) 47.6 14.5 (n=240) 60 1.2 Moderate Mild 40 0.8 83.8 81.9 77.4 None/Trace 0.7 0.2 (n=237) 9.7 5.4 (n=193) 8.6 3.9 (n=180) 7.6 3.2 (n=169) 20 0.4 0 0.0 Baseline Discharge 30 Days 1 Year Discharge/7d 30 Days 1 Year PCRLondonValves.com SH-1743303 AA
What are the essential results? CT Core Laboratory HALT, Paired Analysis (n=150) HALT @ 30d or 1y N=72 0.0% (0) No HALT @ 30d and 1y N=93 0.0% (0) 1-Year Event Rate P-value 30 Days 1 Imaging Endpt 76.0% 14.6% 9.4% All-cause mortality 0.25 HALT severity 50% HALT severity >50% CV mortality 0.0% (0) 0.0% (0) 0.25 No HALT All stroke 2.2% (2) 2.2% (2) 0.74 1 Disabling stroke 0.0% (0) 0.0% (0) -- 68.0% 20.6% 11.4% Year Valve thrombosis 0.0% (0) 0.0% (0) 0.25 Echocardiography n=27* n=91 Change in HALT severity from 30 days 1 year AV gradient (mm Hg) 7.1 4.3 7.8 2.7 0.36 No change Improved 12% AV area (cm2) 1.6 0.4 1.7 0.4 0.53 67% *Only subjects with HALT recorded at 30 days and 1 year are included in the analysis. 21% (n=135, excludes pts on OAC) Worsened PCRLondonValves.com SH-1743303 AA
The essentials to remember This report confirms favorable performance and safety through 1 year in patients with severe aortic stenosis treated with ACURATE neo2 Patients treated with ACURATE neo2 exhibited early improvement in valve haemodynamics and low rates of PVL through 1 year At 1 year, 99% of patients had mild or no/trace PVL (<1% had moderate PVL) No patients exhibited >moderate PVL at any time 1-year rates of all-cause mortality (5.1%) and stroke (3.0%) are comparable to other trials of TAVR patients at intermediate or high surgical risk The presence of HALT: Did not impact patient safety at 1 year Did not significantly affect mean AV gradient or mean AV area PCRLondonValves.com SH-1743303 AA
PCRonline.com CAUTION: In Europe, ACURATE neo and neo2 Aortic Valve Systems are CE-marked. In the USA, ACURATE neo2 is an investigational device and restricted under federal law to investigational use only. Not available for sale.
